Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)

Completed · Phase 3

Conditions studied: Advanced Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma

In brief

The purpose of this study is to compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.

Key facts

Study ID

NCT02231749

Run by

Bristol-Myers Squibb

People needed

1096

Starts

2014-10-16

Expected to finish

2025-03-21

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological confirmation of renal cell carcinoma (RCC) with a clear-cell component
• Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
• No prior systemic therapy for RCC with the following exception:
• One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets vascular endothelial growth factor (VEGF) or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
• Karnofsky Performance Status (KPS) of at least 70%
• Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Tumor tissue [formalin-fixed paraffin-embedded (FFPE) archival or recent acquisition] must be received by the central vendor (block or unstained slides) in order to randomize a subject to study treatment. (Note: Fine Needle Aspiration [FNA] and bone metastases samples are not acceptable for submission)

You may not qualify if…

• Any history of or current central nervous system (CNS) metastases. Baseline imaging of the brain is required within 28 days prior to randomization
• Prior systemic treatment with VEGF or VEGF receptor targeted therapy (including, but not limited to, Sunitinib, Pazopanib, Axitinib, Tivozanib, and Bevacizumab)
• Prior treatment with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
• Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (>10 mg daily Prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll
• Any condition requiring systemic treatment with corticosteroids (>10 mg daily Prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses >10 mg daily Prednisone equivalents are permitted in the absence of active autoimmune disease

Where it is running

• Local Institution - 0057 — La Jolla, California, United States
• Local Institution - 0044 — Los Angeles, California, United States
• Local Institution - 0035 — Los Angeles, California, United States
• Local Institution - 0067 — Stanford, California, United States
• Local Institution - 0138 — New Haven, Connecticut, United States
• Local Institution - 0034 — Washington D.C., District of Columbia, United States
• Local Institution - 0049 — Tampa, Florida, United States
• Local Institution - 0068 — Atlanta, Georgia, United States
• Local Institution - 0038 — Indianapolis, Indiana, United States
• Local Institution - 0042 — Iowa City, Iowa, United States
• Local Institution - 0163 — Fairway, Kansas, United States
• Local Institution - 0048 — Baltimore, Maryland, United States
• Local Institution - 0004 — Baltimore, Maryland, United States
• Local Institution - 0135 — Boston, Massachusetts, United States
• Local Institution - 0110 — Boston, Massachusetts, United States
• Local Institution - 0161 — Boston, Massachusetts, United States
• Local Institution - 0173 — Boston, Massachusetts, United States
• Local Institution - 0046 — Ann Arbor, Michigan, United States
• Local Institution - 0043 — Detroit, Michigan, United States
• Local Institution - 0036 — Buffalo, New York, United States
• Local Institution - 0001 — New York, New York, United States
• Local Institution - 0008 — Charlotte, North Carolina, United States
• Local Institution - 0045 — Durham, North Carolina, United States
• Local Institution - 0007 — Cleveland, Ohio, United States
• Local Institution - 0006 — Duarte, California, United States

Full record on ClinicalTrials.gov

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